NCT07392879 · University of Michigan
Bringing the Outdoors In: Virtual Nature Walks for Depression in Multiple Sclerosis (MS) Patients
What this study is about
This trial explores the use of immersive virtual reality (VR) nature-based experiences as a supplementary treatment for depression in individuals with progressive multiple sclerosis (MS).
View original scientific description
This trial explores the use of immersive virtual reality (VR) nature-based experiences as a supplementary treatment for depression in individuals with progressive multiple sclerosis (MS). This study will evaluate the feasibility and efficacy of at-home VR deployment using the Apple Vision Pro, an advanced device that offers enhanced resolution, immersion, and usability compared to earlier VR systems. The study hypotheses include: * The integration of VR nature-based experiences with standard care will be feasible, acceptable, and will result in greater reductions in depressive symptoms compared to standard care or VR-only interventions. * The integration of VR nature-based experiences with standard care will result in greater reductions in stress and anxiety, better sleep, less insomnia, and improved fatigue compared to standard care alone or VR-only interventions.
Interventions
DEVICE
Virtual Reality
Participant will have 8 weeks of immersive VR nature-based experiences. Participants are expected to use the VR headset three times per week. Headsets will contain a prototype application (app) developed by Explore POV. This app will include approximately one hour of footage showcasing 15-25 different nature experiences, that will shuffle every time participants access it. Participants will have the option to choose between 5, 10, or 15 minutes, sessions while answering weekly surveys regarding their experiences.
OTHER
Standard care
Participants that are in the randomized groups will continue on antidepressants or psychotherapy during the study per their standard care. Participants in the non-randomized group don't receive any treatment for their depression and will continue not to receive anything for this during the study.
Primary outcome measures
Changes to the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression short form 8b scores
Time frame: Baseline, 9-10 weeks and 20-21 weeks
This is an 8-item evaluating various aspects of depression, including negative mood, anhedonia, feelings of worthlessness, and cognitive impairments. Each item is rated on a 5-point Likert scale ranging from never (1) - always (5). Scores range from 8-40 with a higher score indicating greater symptom severity.
Virtual Reality (VR) Sessions completed over 8 weeks
Time frame: 8-week VR intervention
A benchmark of 70% will indicate adequate feasibility and acceptability.
Qualitative feedback on the VR Neuroscience Questionnaire during the intervention (groups 1 and 3)
Time frame: 1-8 weeks (during VR)
The modified scale for this project uses 10 questions that participants will answer about the VR experience, rated from 1 (extremely low or extremely difficult) to 7 (extremely high or extremely easy). The scores range from 10 to 70, with higher scores indicating greater experience. A benchmark of 70% indicates adequate feasibility and acceptability, with participant satisfaction ratings above 80%.
Qualitative feedback with Semi-structured interviews for participants that received VR
Time frame: Weeks 9-10, Weeks 20- 21
Semi-structured interviews with 20 random participants (6-7 from each group) who received the VR treatment to capture participants' subjective experiences at the midpoint and end of the intervention. The interview questions will focus on emotional changes, engagement levels, and feedback on the intervention's implementation.
Enrollment rate
Time frame: Recruitment period (2 years)
Feasibility will be assessed via enrollment. Recruitment will be quantified by enrollment rates relative to the number of eligibility screenings.
Retention rates
Time frame: Baseline - 21 weeks
Feasibility: Retention will be evaluated through the percentage of participants who complete the entire study duration, targeting a benchmark of at least 70%.
Adherence to VR intervention
Time frame: 8-week VR intervention
Feasibility: Adherence to 5-15-minute sessions 3 times per week over 8 weeks
Dropout reasons
Time frame: Baseline - 21 weeks
Hardware/software issues
Time frame: During 8 weeks of VR
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Confirmed diagnosis of progressive Multiple Sclerosis (MS, primary or secondary) by a neurologist or an MS center
- Patient-Reported Outcomes Measurement Information System (PROMIS) Depression T-scores \>55 at baseline
- Ability to provide informed consent and participate in VR sessions at home
- For Some Participants (Groups 1 and 2) currently receiving antidepressant or psychotherapy treatments (Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs), or psychotherapy) for the management of depression
Exclusion criteria
- Severe cognitive impairments or visual deficits that may interfere with VR use, including contraindications like agoraphobia, claustrophobia, or motion sickness
- Current participation in other clinical trials targeting depression
- Severe psychiatric conditions that require hospitalization, or suicidal ideation, passive or active, psychosis, or active substance and alcohol abuse (score greater than 1 on CAGE (Cut down, Annoyed, Guilty, Eye-opener) Adapted to Include Drugs (CAGE-AID))
- Another neurological or autoimmune disease per protocol
- Participants that require vision correction, unless that vision correction is mild (± 1), or the participant has prescription contact lenses.
Where
- Ann Arbor, Michigan
Collaborators
Apple Inc., The International Organization of Multiple Sclerosis Nurses Inc
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 12, 2026 · Source of record for eligibility and locations